Clinical Trial Services
Clinical Development
For any medical innovation to become an important tool in healthcare, the processes of invention, development, and dissemination must be focused and seamless.
HCRI’s trial design team includes Harvard faculty physicians, experienced biostatisticians, and thought leaders from other world-renowned academic institutions. This team designs clinical research programs in all phases of development from first-in-man through Phase IV post approval trials. The team offers expertise during interactions with government agencies in support of the application throughout the regulatory submission process.
The trial design process involves in-depth discussions with sponsors to review literature and associated study materials and prepare for regulatory meetings. In collaboration with sponsors, the team develops written protocols, case report forms and consent documents necessary for agency submission and study conduct.
HCRI also facilitates and participates in production of intermediate and final study reports. The team shares its scientific and medical expertise with the community of practitioners via publication of articles in peer-reviewed journals.
Key components of clinical development include:
Protocol design
- Assessment of industry landscape and sponsors specific needs in product development
- Initiation of in-depth discussion with sponsor to support regulatory interaction
- Selection of appropriate study endpoints
- Development of the trial design, statistical rationale and inclusion and exclusion criteria
- Creation of data collection guidelines
Case Report Form (CRF) design and review
- Capture of information needed to describe the study population
- Delivery of information pertaining to the use of the investigational product
- Analysis of the study endpoints
- Creation of patient CRFs
- Development of mechanism to capture specific adverse events
Produce, review and approve study-related documents including:
- Protocols and design synopses
- Data Safety Monitoring Board (DSMB) charters and Clinical Events Committee (CEC) manuals of procedures (MOPS)
- Interim and final study reports
- Manuscripts for peer review
Medical education materials
- Medical Oversight/Management
- Participation as material experts in regulatory interactions with sponsors
- Review of protocol and case report form
- Oversight of DSMB
- Delivery of CEC services
- Clinical review of report deliverables generated by HCRI